NC Quantum Apex™ H7493912420350Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729783503), received between Jan 24, 2019 and Sep 21, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847257 ↗
• MalfunctionMay 2, 2024Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON ISSUES OCCURRED. THE 20MM X 3.50MM QUANTUM NC APEX BALLOON WAS SELECTED FOR USE. THE BALLOON CATHETER WAS PLACED ON NEGATIVE PRESSURE AND INSERTED INTO THE GUIDE CATHETER. AS THE BALLOON ADVANCED OVER THE AORTIC ARCH, IT WAS NOTED THAT IT APPEARED MINIMALLY INFLATED. THE DEVICE WAS REMOVED, AND THE BALLOON WAS FOUND TO CONTAIN CONTRAST AND WAS NOT FULLY DEFLATED AS IT SHOULD BE WITH NEGATIVE PRESSURE APPLIED. THE DEVICE WAS TESTED OUTSIDE THE PATIENT AND WAS NOT INFLATING AND DEFLATING OPTIMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235135 ↗
• MalfunctionApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 38MM IN LENGTH, 3.5 VESSEL DIAMETER, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE CROSSED THE LESION, A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 20 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709830 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT BREAK SHAFT BREAK OCCURRED. A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, IT WAS NOTICED THAT SHAFT BREAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066700 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE DURING UNPACKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9410240 ↗
• MalfunctionMay 3, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHILE ADVANCING A 20MM X 3.50MM NC QUANTEM APEX IN A COMPLEX LESION, THE SHAFT BROKE. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579406 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST THE ATTEMPT TO PASS OVER THE WIRE, IT WAS OBSERVED THAT THE SHAFT OF THE CATHETER BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545903 ↗
• MalfunctionMar 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCE FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. ANOTHER 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT ALSO RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381553 ↗
• MalfunctionMar 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCE FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. ANOTHER 20MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT ALSO RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381356 ↗
• MalfunctionJan 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-JAN-2019. IT WAS REPORTED THAT LOADING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 20MM X 3.50MM NC QUANTUM APEX AND A 2.50MM X 12MM EMERGE BALLOON CATHETERS WERE SELECTED FOR USE; HOWEVER, BOTH DEVICES COULD NOT BE LOADED OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED SINCE THE DEVICES DID NOT ENTER THE PATIENT'S BODY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HOLE IN SHAFT MATERIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273668 ↗